ImportRefusal LogoImportRefusal

Alpine Electronics Inc

⚠️ Moderate Risk

FEI: 1000583404 • Shinagawa, Tokyo • JAPAN

FEI

FEI Number

1000583404

📍

Location

Shinagawa, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 1-8, Nishigotanda, Shinagawa, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
7/30/2002
Latest Refusal
4/16/2002
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
7/30/2002
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
New Orleans District Office (NOL-DO)
5/13/2002
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
New Orleans District Office (NOL-DO)
4/16/2002
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Alpine Electronics Inc's FDA import refusal history?

Alpine Electronics Inc (FEI: 1000583404) has 3 FDA import refusal record(s) in our database, spanning from 4/16/2002 to 7/30/2002.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Alpine Electronics Inc's FEI number is 1000583404.

What types of violations has Alpine Electronics Inc received?

Alpine Electronics Inc has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Alpine Electronics Inc come from?

All FDA import refusal data for Alpine Electronics Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.